1. Field of the Invention
The present invention generally relates to an incontinence device.
2. Description of the Related Art
By way of background, it is well appreciated the female pelvic region includes portions of the female reproductive system, female gastrointestinal system and the female urinary system. The female pelvic region is shown in FIGS. 1 and 2, and includes a vagina 200, a cervix 210, a uterus 212, a urethra 208, a bladder 214 and a symphysis pubis 216. The vagina 200 includes an introital opening 218 that exits the human body and contains a vaginal canal 202 extending from the introital opening 218 to the cervix 210. The vaginal canal 202 has a length that ranges from between about 4 to about 6 inches in most women. The cervix 210 is the entrance to the uterus and is located between the upper aspect of the vaginal canal 202 and the uterus 212. The vaginal canal 202 has an inner periphery 220.
The inner periphery 220 of the vaginal canal is composed of a right lateral wall 222, a left lateral wall (not shown), an anterior wall 206, and a posterior wall 204. The four walls encompass the entire 360 degrees of the inner periphery 220. The anterior wall 206 is located closest to the urethra 208 and the urethra 208 is located between the symphysis pubis 216 and the vagina 200.
The vaginal canal 202 is commonly divided into three approximately equal sections, that is, the inferior third 236, the middle third 237 and the superior third 238, each representing about one-third of the overall length. Each section is approximately 2 inches in length. The inferior third 236 of the vaginal canal 202 is the most important section for alleviating female urinary incontinence because of its proximity to the urethra 208. The inferior third 236 of the vaginal canal 202 is the location affected by placement of vaginal insert devices which alleviate conditions of female incontinence, regardless of where in the vagina 202 the bulk of the device rests after insertion. In the erect female, the middle third 237 of the vaginal canal 202 is horizontally offset from the inferior third 236 of the vaginal canal 202 which is substantially parallel to the urethra 208. The urethra 208 is situated between the inferior third 236 of the vaginal canal 202 and the symphysis pubis 216, which is a bony structure situated adjacent to a front portion of the human torso and may be referred to as the bladder neck region.
The urethra 208, also referred to as a urethral tube, is a hollow tubular structure positioned anterior to the vaginal canal 202. The urethra 208 extends from a first opening 226 that exits the human body to a second opening 228 situated at the lower surface of the bladder 214. The posterior urethrovesical angle is formed where the urethra 208 enters the bladder 214. The urethra 208 has a length of about 1.5 inches in most women. The urethra 208 functions to discharge urine, which is temporarily stored in the bladder 214, from the human body. The urethra 208 has a plurality of urethral sphincter muscles 232 located along the length of its inner periphery. The urethral sphincter muscles 232 are situated below the opening 228 and are ring like muscles that normally maintain constriction of the urethra 208 to prevent the passage of urine. The relaxation of the urethral sphincter muscles 232 by normal physiological functioning will permit urine to be voluntarily expelled from the body.
The pubococcygeal muscle 233 originates at the symphysis pubis 216 and extends to the inferior extent of the coccyx 234 with a passage in the center of the muscle through which the rectum 235, vagina 200 and urethra 208 pass. The posterior portion of the passage through the pubococcygeal muscle 233 normally provides support to the posterior portion of the urethra 208 through the soft tissues of the rectum 235 and vagina 200 which assist in maintaining constriction of the urethra 208 to prevent the passage of urine. When the pubococcygeal muscle 233 stretches due to childbirth or generally relaxes due to the normal aging process, support to the posterior portion of the urethra 208 is reduced and unintentional flow of urine through the urethra 208 may occur, particularly when pressure is applied to the bladder 214 during a cough or other abdominal contraction. This condition is known as stress incontinence. Replacing or supplementing support to the posterior side of the urethra 208 can help to prevent the unintentional flow of urine through the urethra 208.